FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics /

Preparing for FDA pre-approval inspections /
Published: (1999)

Prescription drugs : FDA's oversight of the promotion of drugs for off-label uses : report to the Ranking Member, Committee on Finance, U.S. Senate.
Published: (2008)

Drug safety: FDA has faced persistent challenges overseeing foreign drug manufacturing : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representative /
by: Denigan-Macauley, Mary
Published: (2024)

FDA's Faulty Safeguards Against Corruption : Concerns over Debarment Use and Authority.
Published: (2008)

Complete accounts of integrated drug discovery and development : recent examples from the pharmaceutical industry /
Published: (2018)

Complete accounts of integrated drug discovery and development : recent examples from the pharmaceutical industry.
Published: (2020)

FDA-approved bargain drugs : generic products must meet high standards.
Published: (2003)

FDA drug bulletin.
Published: (1971)

The administration's FDA reforms and reduced biopharmaceutical drug prices /
Published: (2018)

Development and evaluation of drugs : from laboratory through licensure to market /
by: Lee, Chi-Jen
Published: (2003)

Drug safety : better data management and more inspections are needed to strengthen FDA's foreign drug inspection program : report to congressional requesters.
Published: (2008)

El proceso del desarrollo de las drogas y la FDA : cómo la agencia asegura que las drogas sean seguras y efectivas.
Published: (2002)

FDA regulatory affairs /
Published: (2014)

FDA's review process for new drug applications : a management review.
Published: (2003)

Drug compounding, FDA has taken steps to implement compounding law, but some states and stakeholders reported challenges : report to Congressional Committees.
Published: (2016)

FDA's generic drug enforcement and approval process : hearings before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Second Congress, first session, March 7 and June 5, 1991.
Published: (1992)

Drugs@FDA.

Drugs : from discovery to approval /
by: Ng, Rick
Published: (2004)

Real world drug discovery : a chemist's guide to biotech and pharmaceutical research /
by: Rydzewski, Robert M.
Published: (2008)

Human drug targets : a compendium for pharmaceutical discovery /
by: Zanders, Edward D.
Published: (2016)

FDA administrative enforcement manual /
by: Parker, Florence R.
Published: (2005)

Las drogas baratas aprobadas por la FDA : los productos genéricos deben satisfacer altos niveles.
Published: (2004)

Dose optimization in drug development /
Published: (2006)

Practical medicinal chemistry with macrocycles : design, synthesis, and case studies /
Published: (2017)

FDA regulation of over-the-counter (OTC) drugs : overview and issues for Congress /
by: Bodie, Agata
Published: (2021)

Drug compounding for animals : FDA could improve oversight with better information and guidance : report to congressional committees.
Published: (2015)

Membranes and barriers : targeted drug delivery /
Published: (1995)

Conference on drug design and discovery technologies /
Published: (2020)

Ways to successful strategies in drug research and development /
by: Sedlacek, H. H.
Published: (1996)

Evaluation of drug candidates for preclinical development : pharmacokinetics, metabolism, pharmaceutics, and toxicology /
Published: (2010)

Drug discovery and development /
Published: (2006)

Allegations of FDA abuses of authority : hearing before the Subcommittee on Oversight and Investigations of the Committee on Commerce, House of Representatives, One Hundred Fourth Congress, first session, July 25, November 15, and December 5, 1995.
Published: (1996)

FDA's drug approval process : up to the challenge? : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, first session, on examining Food and Drug Administration's (FDA) drug approval process, focusing on FDA's drug approval process after a sponsor demonstrates that their benefits outweigh their risks for a specific population and use, and that the drug meet [as printed] meets standards for safety and efficacy, March 1, 2005.
Published: (2005)

FDA's drug approval process : up to the challenge? : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, first session, on examining Food and Drug Administration's (FDA) drug approval process, focusing on FDA's drug approval process after a sponsor demonstrates that their benefits outweigh their risks for a specific population and use, and that the drug meet [as printed] meets standards for safety and efficacy, March 1, 2005.
Published: (2005)

Target validation in drug discovery /
Published: (2007)

NMR spectroscopy in drug development and analysis /
by: Holzgrabe, U. (Ulrike)
Published: (1999)